How many recalls does Mako Surgical Corporation have?

Recalert has 11 U.S. recalls on record for Mako Surgical Corporation, published between November 28, 2012 and November 25, 2020.

What was the most recent Mako Surgical Corporation recall?

FDA recall Z-0472-2021, published November 25, 2020: Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dis…

Which agencies have handled Mako Surgical Corporation recalls?

Mako Surgical Corporation appears as the recalling firm in recalls from: FDA (11).

Mako Surgical Corporation: 11 recalls on record

Recalls filed with 1 agency: FDA (11).

First recall on record: November 28, 2012. Most recent: November 25, 2020.

Risk classification: Class II: 11

Most recent recalls

Date	Agency	Product	Recall number
November 25, 2020	FDA	Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#…Z-0472-2021	Z-0472-2021
May 16, 2018	FDA	RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee r…Z-1644-2018	Z-1644-2018
September 20, 2017	FDA	Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive …Z-3130-2017	Z-3130-2017
September 20, 2017	FDA	Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic Sy…Z-3131-2017	Z-3131-2017
July 26, 2017	FDA	MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the s…Z-2741-2017	Z-2741-2017
May 4, 2016	FDA	RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for…Z-1583-2016	Z-1583-2016
December 24, 2014	FDA	RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for u…Z-0828-2015	Z-0828-2015
December 24, 2014	FDA	RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument desi…Z-0830-2015	Z-0830-2015
December 24, 2014	FDA	RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument de…Z-0829-2015	Z-0829-2015
March 12, 2014	FDA	Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used wi…Z-1132-2014	Z-1132-2014
November 28, 2012	FDA	The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assis…Z-0385-2013	Z-0385-2013

Questions about this company

How many recalls does Mako Surgical Corporation have?: Recalert has 11 U.S. recalls on record for Mako Surgical Corporation, published between November 28, 2012 and November 25, 2020.
What was the most recent Mako Surgical Corporation recall?: FDA recall Z-0472-2021, published November 25, 2020: Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dis…
Which agencies have handled Mako Surgical Corporation recalls?: Mako Surgical Corporation appears as the recalling firm in recalls from: FDA (11).

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Mako Surgical Corporation: 11 recalls on record

Most recent recalls

Questions about this company

Do you carry products from Mako Surgical Corporation? Check your whole catalog free against 80,000+ recalls.

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